Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Be ≥18 years of age (or the higher legal age in the jurisdiction in which the study is taking place) at the time of informed consent

• Has documented diagnosis of MM according to the IMWG diagnostic criteria (Rajkumar 2011).

• Has received 2 or more prior MM therapies including a PI, IMiD and CD38 antibody.

• Has an ECOG performance status (Oken 1982) of 0 to 1.

• Measurable disease at screening, as assessed by local laboratory, defined by any of the following:

‣ Serum M-protein level ≥0.5 g/dL; or

⁃ Urine M-protein level ≥200 mg/24 hours; or

⁃ Light chain MM without measurable M-protein in the serum or the urine: serum free light chain (sFLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.

⁃ For participants without measurable disease in the serum, urine, or involved FLC, presence of plasmacytomas (≥2 cm).

• Human immunodeficiency virus-positive participants are eligible if they meet all of the following:

‣ No detectable viral load (i.e., \<50 copies/mL) at screening

⁃ CD4+ count \>300 cells/mm3 at screening

⁃ No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 6 months of screening

⁃ Receiving highly active antiretroviral therapy (HAART). Any changes in HAART due to resistance/progression should occur at least 3 months prior to enrollment. A change in HAART due to toxicity is allowed up to 4 weeks prior to enrollment.

• Adequate organ system function

• Body weight \>35 kg.

• A participant of childbearing potential must have a negative highly sensitive serum (β-hCG) at screening and within 72 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study.

• A participant must agree to abide by protocol defined contraceptive requirements for the duration of the study

• A participant must sign an ICF indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.

• A participant is required to stay within 30 minutes of transportation to the site and remain in the company of a competent adult at all times until 48 hours following administration of all doses within the teclistamab or talquetamab step-up dosing schedule

• A participant must agree to carry the study participant identification wallet card at all times.

• A participant must comply with all the protocol requirement procedures, including measuring and recording of body temperature and blood oxygen saturation twice daily (≥8 hours apart) during the first 2 cycles of teclistamab or talquetamab treatment and coming to the study site for safety assessments.

• A participant and the accompanying competent adult must be made aware of the presenting sign sand symptoms of teclistamab- or talquetamab- associated toxicities, including but not limited to CRS, ICANS, infections, etc. The accompanying competent adult must watch the participant at all times for teclistamab- or talquetamab- associated toxicities, until 48 hours after the first treatment dose of teclistamab or talquetamab.

Locations
United States
Arizona
Arizona Oncology Associates
RECRUITING
Tucson
Colorado
Colorado Blood Cancer Institute
RECRUITING
Denver
Rocky Mountain Cancer Center
RECRUITING
Denver
Delaware
Medical Oncology Hematology Consultants
RECRUITING
Newark
Florida
Florida Cancer Specialists
RECRUITING
Lake Mary
Maryland
Maryland Oncology Hematology
RECRUITING
Columbia
Minnesota
Minnesota Oncology Hematology
RECRUITING
Minneapolis
Ohio
Oncology Hematology Care
RECRUITING
Cincinnati
Oregon
Oncology Associates of Oregon
RECRUITING
Eugene
Tennessee
TriStar Bone Marrow Transplant
RECRUITING
Nashville
Texas
Texas Oncology
RECRUITING
Austin
Texas Oncology - San Antonio
RECRUITING
San Antonio
Texas Oncology - Northeast Texas
RECRUITING
Tyler
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Virginia Oncology Associates
RECRUITING
Norfolk
Blue Ridge Cancer Center
RECRUITING
Roanoke
Contact Information
Primary
Sarah Cannon Development Innovations, LLC
SCRI.InnovationsMedical@scri.com
1-844-710-6157
Time Frame
Start Date: 2023-10-23
Estimated Completion Date: 2026-03
Participants
Target number of participants: 75
Treatments
Experimental: Teclistamab
Participants will receive step up dosing of Teclistamab following the recommended dosage of TECVAYLI™ USPI followed by weekly dosing for twelve 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 12). Teclistamab dosing may be reduced to once every 2 weeks for participants who achieve partial response (PR) or better after 6 months of therapy. Participants not responding to or progressing after prior response to treatment with teclistamab can be re-screened and enrolled into the talquetamab arm.
Experimental: Talquetamab
Participants will receive step up dosing of Talquetamab following the recommended dosage of TALVEY™ USPI followed by every 2 week dosing for six 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 6). Talquetamab dosing may be reduced to once every 4 weeks for participants who achieve very good partial response (VGPR) or better after Cycle 4. Participants in the talquetemab arm cannot be re-screened for or re-enrolled into the teclistamab arm.
Related Therapeutic Areas
Sponsors
Leads: SCRI Development Innovations, LLC
Collaborators: Johnson & Johnson

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.